Enhancing community pharmacy’s role for the benefit of patients
 
A range of measures can be introduced to make greater use of community pharmacies as the navigator of medicine shortage solutions on behalf of patients, efficiently and effectively. Some of these have been implemented, but only in some countries, and even then they are often too limited and constrained in their approach, and do not enable pharmacists to use their potential scope of practice. Measures recommended by the WPC are described below.

1 - In some countries measures have been implemented to allow community pharmacists to dispense a substitute for the prescribed medicine or brand after a supply shortage has been officially declared for that medicine. While these measures have been important they are often slow to take effect due to bureaucratic response times. They are also restrictive in their approach. They do not allow flexibility for individual patient circumstances and do not address localised shortage situations. If a patient’s situation falls outside of the narrow limits of these arrangements when they encounter a shortage issue, they will usually need to obtain a new prescription for an alternative product. A more responsive, flexible and streamlined system is required. In accordance with protocols suitable for each country’s unique circumstances, community pharmacists should be enabled through legislation to facilitate appropriate solutions for patients using their full scope of practice, in particular through the ability to substitute the most appropriate alternative for an unavailable product which may include a change of brand, strength, formulation, dosage or drug (as occurs in the majority of Canadian provinces, for example). This will minimise the patient impact of national or regional medicines supply disruptions and optimise patient care, while also alleviating pressure on prescribers.

2 - Streamlined two-way digital communication channels should be in place between pharmacies and prescribers to enhance efficiency in finding solutions for patients and to ensure prescribers have timely and reliable access to information in instances where pharmacists initiate a medicine substitution in line with national protocols.

3 - Governments and other funders of community pharmacy services should prioritise a well-distributed, viable and appropriately resourced network of community pharmacies in all areas of each country, both geographically and socio-economically, including specific recognition and remuneration for community pharmacy’s role in the management of medicine shortages. This will provide optimal access for patients to pharmacies that have capacity to effectively manage supply chain problems so that the most vulnerable patient populations are not subject to adverse health outcomes.

4 - The quantity of the medicine that can be supplied to each patient should be temporarily reduced, in some circumstances, to ensure that limited supplies can be made available to the largest number of people and to prevent inappropriate individual stockpiling. This should be done according to national supply control measures supported by the competent authorities.

5 - Pharmacies should have the permission to compound medicines and be provided with suitable funding mechanisms for doing so.

6 - Centralised monitoring of real world data from community pharmacies (patient deidentified) should be implemented to track the national and localised impacts of medicines shortages and provide regulators and supply chain participants with information upon which to base their decisions. For example, in Spain’s CisMED system provides a quantification of medicines shortages at a regional and national level and an “early warning system” that can allow health systems to anticipate demand and react quickly4. Importantly, these monitoring systems should be designed to not place any additional burden on pharmacy teams. Such systems are in the national and international interest and require greater investment from governments in technology and data analytics.

Community pharmacy’s current role
 
When there is a shortage of a particular medicine, healthcare professionals including community pharmacists must help patients navigate the situation by identifying and providing substitute treatments so that treatment can continue, and to ensure appropriate and safe use of therapeutic alternatives by intensive counselling. Often, the pharmacist’s ability to address the problem directly and efficiently is constrained by legislation, regulation or other hurdles.
 
Mitigating the impact on patients, to ensure continuity and safety of treatment, is the number one priority of community pharmacists when dealing with shortages. However, this is a significant drain on pharmacy resources. For example, in Germany, 62% of pharmacy owners have reported that more than 10% of their employees’ working time is spent procuring substitute products for patients due to shortages. Similarly, a 2019 survey by the Canadian Pharmacists Association found that managing drug shortages can occupy up to 20% of their time. This places a great burden on staff and resources, with no compensation.

Causes and responses

 
The main causes of medicine shortages include raw material shortages, manufacturing problems, surges in demand, regulatory issues, labour shortages, transportation bottlenecks, political instability, economic factors such as drug pricing, and market dynamics.

 
Governments and regulators around the world are developing and implementing strategies aimed at reducing the impact of shortages. These include improvements to reporting, enhanced supply chain monitoring, adjustments to drug pricing policies, coordinated stockpiling2, and moves to expand domestic manufacturing. These measures are worthwhile, and have localised benefits. However, at least in the short to medium term, none of these measures can adequately address this global problem.

January 2024 Position Statement - World Pharmacy Council

View the complete statement, including references and footnotes: World Pharmacy Council Position Statement on Medicine Shortages.

Medicine shortages are a worsening global problem

Medicine shortages are a major global problem with serious ramifications for health outcomes. Shortages result in patients being deprived of the medicines they have been prescribed or advised to take.

Data from many different sources has shown that the situation is worsening. For example, the 2023 Pharmacy Pressures Survey conducted by Community Pharmacy England found that 92% of pharmacies are dealing with medicine supply issues daily, an increase from 67% in the 2022 survey. Even more worryingly, 87% of pharmacy staff reported that patient health is put at risk because of medicine supply issues.

Also, a national study in Portugal in April 2019 found that 52.2% of patients experienced a shortage issue in the previous 12 months, 21.5% had to see a physician to change the prescription, and 5.7% declared treatment discontinuation because of the shortage.

January 29, 2024

Position Statement:
Medicine Shortages

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If you are an individual, please note that membership of the World Pharmacy Council is not available to individuals. The Council’s full members are community pharmacy representative organisations, and application for affiliate membership is open only to companies and other organisations that have an interest in the field of community pharmacy.

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